Patients and physicians rely upon the accuracy of laboratory testing when making decisions about medical care. Inaccurate tests can cause patients to forego medical procedures when they get the “all clear,” or lead to unnecessary treatment when diagnosed with diseases and medical conditions they do not have.
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Regulatory compliance of test manufacturers is lax and not actively enforced by the FDA. The agency has a hodgepodge of regulations that allow tests to be utilized even though the veracity of their results and testing procedures have not been proven. Moreover, the sheer number of tests and their complexity has exceeded the FDA’s ability to research and verify each test on the market.
“The market has been flooded with home test kits that will look for everything from HIV and herpes, to tests that will look for genetic links to heart disease. Concerned patients purchase and trust these tests from private laboratories without little to no knowledge of their accuracy,” warned Reno defective medical device lawyer Matthew L. Sharp.
Equally as troubling is that the FDA has no information on the number of adverse events resulting from inaccurate testing. The agency simply doesn’t require laboratories to report such events. Further, the agency does not require test manufacturers to inform the government if it becomes known that one of their tests led to a death or serious injury.
“There are enormous gaps in FDA oversight that are large enough to drive the plague through. While some diagnostic tests are regulated, others are not; and the government has shown little motivation to close this gap until now,” chastised Reno defective medical device lawyer Matthew L. Sharp.
Congress is currently weighing actions that would increase the FDA’s statutory authority to enforce tougher standards that would better ensure patient safety. However, it is unlikely that such a move will come quickly, or without serious compromises that could ultimately compromise patient safety in the future. For now, patients and physicians will be required to rely upon tests that may, or may not, give them an accurate medical diagnosis.